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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K211655
Device Name aPROMISE
Applicant
EXINI Diagnostics AB
Ideon Science Park, Scheelevägen 27
Lund,  SE SE-223 70
Applicant Contact Aseem Anand
Correspondent
Biologics Consulting Group
1555 King Street
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/28/2021
Decision Date 07/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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